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A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

NCT07116174 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-03-31

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is:

What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase?

Participants:

* Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria
* Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits
* Subjects who complete the treatment will be followed up after 2 weeks

Conditions

  • Diabetic Foot Ulcer (DFU)

Interventions

BIOLOGICAL

Xcell Amnio Matrix

A lyophilized amniotic membrane allograft

DRUG

Standard of Care (SOC)

The SOC will be based on investigator's choice

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • New Horizon Medical Solutions

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-08-15
Completion
2026-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07116174 on ClinicalTrials.gov